CheckMark Labrecruitment

Gepubliceerd: ongeveer 1 maand geleden

(Senior) Technical eLIMS Specialist QC

Leiden
€2,624 - €3,310 (Maand)
Gepubliceerd: ongeveer 1 maand geleden
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Waar ga je aan de slag - Where will you work

A global biotech company that focuses on the development, pro­duction and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.

Wat ga je doen - What will your job be

Do you have strong experience working with eLIMS in a regulated medical industry and would you like to use this experience to support digatilization/automation projects while being involved in COVID-19 release and stability testing? Then keep on reading!

As Technical eLIMS Specialist QC you will work within the eLIMS Center of Excellence (CoE). You are the expert in data setups in the eLIMS system to support lab processes including paperless product release and CofA generations. This includes maintaining and reviewing high quality data setups, integrating instuments/applications and translating specifications within the eLIMS system. Currently two positions as a Technical eLIMS Specialist QC are available to support the COVID-19 Release & Stability testing:

Technical eLIMS Specialist QC:

  • Build and maintain work items and super sample templates such as Drug Substance & Drug Product Specifications and Stability studies to support release and stability testing
  • Maintain CBER automated reports
  • Maintain system related documentations (procedures, events etc) with the appropriate applications (Docspace, Trackwise, Clearquest, HP-ALM or other designed systems)

Senior Technical eLIMS Specialist QC:

  • Build and maintain work items, super sample templates, CBER automated reports and system related documentations
  • eLIMS Site Key User for an important CMO
  • Lead eLIMS projects within QC Operations, e.g. implementation of iLABs projects, harmonization / standardization of processes. This includes mentoring, leading and training team members.


Wat vragen wij - What are we looking for

Currently two positions as a Technical eLIMS Specialist QC are available to support the COVID-19 Release & Stability testing. For both positions a HBO/BSc degree or equivalent is required in combination with broad knowledge and experience with cGMPs, applicable regulations (e.g. FDA, ICH Q8, 9, 10), and risk management. Furthermore you need to be able to manage multiple issues, organize activities, prioritize and maintain clear line of communication with the eLIMS CoE lead. 

Technical eLIMS Specialist QC:

  • Minimum of 2 years of experience working in a regulated medical industry (pharmaceuticals, medical devices or diagnostics)
  • Knowledge and experience with LIMS and Quality system

Senior Technical eLIMS Specialist QC:

  • Minimum of 4-6 years of working experience in a regulated medical industry (pharmaceuticals, medical devices or diagnostics)
  • Strong knowledge and experience with LIMS, Quality system and Master Data Management
  • Extensive other experience with analytical testing, quality control or IT is preferred.

Wat hebben we te bieden - What do we offer
  • Long term position, which starts with a 6 months contract via CheckMark Labrecruitment
  • Salary indication from €2624 gross per month based on a full-time position
  • Full-time position (40 hours/week), 32 hours is discussable
  • Working remotely from home is possible

Wil je meer weten - More information

Neem voor meer informatie contact op met Jurjen Wilschut: 088 00 21 122 // 06 302 47 453 of Sebastiaan Loriaux 088 0021 126 // 06 1587 5174
Vacaturenummer: 6892

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